- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687218
Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Lima, Peru
- Asociación Civil Impacta Salud y Educación (IMPACTA)
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico Medical Sciences Campus - Maternal Infant Studies Center (CEMI)
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Cape Town, South Africa
- Desmond Tutu HIV Foundation
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Chiang Mai, Thailand, 50202
- Research Institute for Health Sciences - Chiang Mai University
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Nonthaburi, Thailand, 11000
- Thailand MOPH - US CDC Collaboration (TUC)
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California
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San Francisco, California, United States, 94102
- HIV Research Section, San Francisco - Department of Public Health
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Massachusetts
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Boston, Massachusetts, United States, 02115
- The Fenway Institute/Fenway Community Health
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center (UPMC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or transgender female > age of 18 at Screening
- Able and willing to provide written informed consent
- HIV-1 uninfected at Screening and Enrollment
- Able and willing to provide adequate locator information, as defined in site SOP
- Available to return for all study visits, barring unforeseen circumstances and willing to comply with study participation requirements
- In general good health at Screening and Enrollment, as determined by the site IoR or designee
- Per participant report, a history of consensual RAI at least once in the past 3 months
- Per participant report at Screening and Enrollment, agrees not to engage in receptive or insertive sexual activity with another study participant for the duration of study participation.
- Willing to use study-provided condoms for the duration of the study for penetrative intercourse
- Willing to not take part in other research studies involving drugs, medical devices, vaccines or genital products for the duration of study participation (including the time between Screening and Enrollment)
Men and transgender females who agree to take part in the PK, PD and Mucosal Immunology Subset, must also agree to abstain from:
- Inserting anything into the rectum, including abstaining from RAI for 72 hours after the collection of biopsies
- Taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and/or other drugs that are associated with increased likelihood of bleeding following mucosal biopsy collection for 72 hours prior to and following the collection of biopsies.
Exclusion Criteria:
At Screening, participant-reported symptoms, and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection requiring treatment per current World Health Organization (WHO) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic Chlamydia trachomatis (CT) infection, Neisseria gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts.
Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required.
In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after the screening visit will be allowed
- History of inflammatory bowel disease as reported by participant history
At Screening:
- Positive for hepatitis B surface antigen
- Positive for hepatitis C antibody
- Hemoglobin < 10.0 g/dL
- Platelet count less than 100,000/mm3
- White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3
- Calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL)
- Serum creatinine > 1.3 x the site laboratory upper limit of normal (ULN)
- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN
- PK, PD and Immunological Subset only: International normalized ratio (INR) > 1.5× the site laboratory ULN or partial thromboplastin time (PTT) > 1.25× the site laboratory ULN
- Known allergy to methylparaben and/or propylparaben
- Known allergy to any of the study products.
Per participant report, use of the following medications and/or products within 12 weeks prior to screening, and/or anticipated use or unwillingness to abstain from use throughout study participation:
- Any investigational products
- Systemic immunomodulatory medications
- Use of Heparin, including Lovenox®
- Warfarin
- Plavix® (clopidogrel bisulfate)
- Rectally-administered medications or products, containing N-9 or corticosteroids
- By participant report, use of post-exposure prophylaxis (PEP) for HIV exposure within the 12 weeks prior to screening or anticipated use during study participation.
- Symptoms suggestive of acute HIV seroconversion at Screening and Enrollment
- Has any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements. Such conditions may include, but are not limited to, colorectal abnormalities, substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or psychiatric disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Group 1
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
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Active Comparator: Group 2
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
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Active Comparator: Group 3
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
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Active Comparator: Group 4
Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
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Active Comparator: Group 5
Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)
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Active Comparator: Group 6
Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety: Grade 2 or Higher Adverse Events
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel.
Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel.
Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC.
Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel.
Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens.
This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire.
Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel.
Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C.
Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates.
Final Converged Rates were measured first via self-report through Short Message Service (SMS).
The clinic staff also reported the most likely number of doses taken.
Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results.
Note that these final judgement data are missing if PK results are missing.
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacodynamics
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Mucosal Immunity
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Correlation Between PK and Adherence
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To assess correlation of PK with adherence measures
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Factors Associated With Adherence
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Sexual Activity and Condom Use
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To examine whether sexual activity or condom use varies by product used
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Product Sharing
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To determine the level of sharing of study products with non-participants and to assess with whom products are shared
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Problem Practices
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
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To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use
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27 weeks (three 8-week product use periods with 1-week washout periods between them)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ross D. Cranston, MD, FRCP, University of Pittsburgh Medical Center (UPMC)
- Study Chair: Javier R. Lama, MD, MPH, Asociación Civil Impacta Salud y Educación (IMPACTA)
Publications and helpful links
General Publications
- Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis. 2017 Mar 1;64(5):614-620. doi: 10.1093/cid/ciw832.
- Carballo-Dieguez A, Balan IC, Brown W 3rd, Giguere R, Dolezal C, Leu CS, Marzinke MA, Hendrix CW, Piper JM, Richardson BA, Grossman C, Johnson S, Gomez K, Horn S, Kunjara Na Ayudhya RP, Patterson K, Jacobson C, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla C, Lama J, McGowan I, Cranston RD. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One. 2017 Jul 27;12(7):e0181607. doi: 10.1371/journal.pone.0181607. eCollection 2017.
- Giguere R, Brown W III, Balan IC, Dolezal C, Ho T, Sheinfil A, Ibitoye M, Lama JR, McGowan I, Cranston RD, Carballo-Dieguez A. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc. 2018 Apr 1;25(4):393-400. doi: 10.1093/jamia/ocx081.
- Carballo-Dieguez A, Giguere R, Dolezal C, Leu CS, Balan IC, Brown W 3rd, Rael C, Richardson BA, Piper JM, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla CD, Lama JR, McGowan I, Cranston RD; MTN-017 Protocol Team. Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men. AIDS Behav. 2017 Dec;21(12):3336-3345. doi: 10.1007/s10461-017-1969-1.
- Giguere R, Rael CT, Sheinfil A, Balan IC, Brown W 3rd, Ho T, Dolezal C, Leu CS, Liu A, Mayer KH, Lama JR, McGowan I, Carballo-Dieguez A, Cranston RD; MTN-017 Protocol Team. Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav. 2018 Feb;22(2):388-401. doi: 10.1007/s10461-017-1890-7.
- Brown W 3rd, Giguere R, Sheinfil A, Ibitoye M, Balan I, Ho T, Brown B, Quispe L, Sukwicha W, Lama JR, Carballo-Dieguez A, Cranston RD. Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform. 2018 Apr;80:78-86. doi: 10.1016/j.jbi.2018.02.018. Epub 2018 Mar 6.
- Cranston RD, Carballo-Dieguez A, Gundacker H, Richardson BA, Giguere R, Dolezal C, Siegel A, KunjaraNaAyudhya RP, Gomez K, Piper JM, Lama JR, McGowan I; MTN-017 Protocol Team. Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women. Int J STD AIDS. 2019 Feb;30(2):154-162. doi: 10.1177/0956462418797864. Epub 2018 Oct 18.
- Leu CS, Giguere R, Bauermeister JA, Dolezal C, Brown W 3rd, Balan IC, Richardson BA, Piper JM, Lama JR, Cranston RD, Carballo-Dieguez A. Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care. 2019 Mar;31(3):379-387. doi: 10.1080/09540121.2018.1533223. Epub 2018 Oct 14.
- Liu AY, Norwood A, Gundacker H, Carballo-Dieguez A, Johnson S, Patterson K, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Mayer KH, Zorrilla C, Buchbinder S, Piper JM, Lama JR, Cranston RD. Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017). J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):516-520. doi: 10.1097/QAI.0000000000002066.
- Balan IC, Giguere R, Brown W 3rd, Carballo-Dieguez A, Horn S, Hendrix CW, Marzinke MA, Ayudhya RPKN, Patterson K, Piper JM, McGowan I, Lama JR, Cranston RD; MTN-017 Protocol Team. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017. AIDS Behav. 2018 Mar;22(3):986-995. doi: 10.1007/s10461-017-1955-7.
- McGowan IM, Kunjara Na Ayudhya RP, Brand RM, Marzinke MA, Hendrix CW, Johnson S, Piper J, Holtz TH, Curlin ME, Chitwarakorn A, Raengsakulrach B, Doncel G, Schwartz JL, Rooney JF, Cranston RD. An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate. AIDS Res Hum Retroviruses. 2022 Apr;38(4):279-287. doi: 10.1089/AID.2021.0115. Epub 2021 Oct 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protective Agents
- Cryoprotective Agents
- Tenofovir
- Emtricitabine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Glycerol
Other Study ID Numbers
- MTN-017
- 5UM1AI068633 (U.S. NIH Grant/Contract)
- 11857 (Other Identifier: DAIDS protocol #)
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